NCT03884426

Brief Summary

Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
6 years until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

11 years

First QC Date

March 21, 2013

Last Update Submit

August 27, 2021

Conditions

Mitral Valve ProlapseGenetic Disease

Keywords

Mitral valve prolapsegeneticechocardiography

Outcome Measures

Primary Outcomes (1)

  • MVP defined by a superior displacement of at least 2 mm

    MVP defined by a superior displacement of at least 2 mm

    At Day 0

Secondary Outcomes (4)

  • Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)

    At Day 0

  • Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)

    At Day 0

  • Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)

    At Day 0

  • Comprehensive mitral valve apparatus characterization per size of items

    At Day 0

Other Outcomes (1)

  • Incidence of cardiac or clinical defects associated with MVP

    At Day 0 Follow-up will be carried out at 5 and 10 years

Study Arms (2)

Patients with MVP

The patients concerned are patients with known or recently discovered Barlow-type mitral prolapse, whatever the degree of severity.

Normal relatives

Related healthy patients, for an average of 6 individuals per family

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both sex of any age with typical mitral valve prolapse and relatives examined during familial screening

You may qualify if:

  • Patients of any age
  • with typical mitral valve prolapse
  • relatives examined during familial screening

You may not qualify if:

  • Refusal of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brest University Hospital

Brest, 29200, France

NOT YET RECRUITING

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Rennes University Hospital

Rennes, 35033, France

RECRUITING

Related Publications (1)

  • Huttin O, Girerd N, Jobbe-Duval A, Constant Dit Beaufils AL, Senage T, Filippetti L, Cueff C, Duarte K, Fraix A, Piriou N, Mandry D, Pace N, Le Scouarnec S, Capoulade R, Echivard M, Sellal JM, Marrec M, Beaumont M, Hossu G, Trochu JN, Sadoul N, Marie PY, Guenancia C, Schott JJ, Roussel JC, Serfaty JM, Selton-Suty C, Le Tourneau T. Machine Learning-Based Phenogrouping in MVP Identifies Profiles Associated With Myocardial Fibrosis and Cardiovascular Events. JACC Cardiovasc Imaging. 2023 Oct;16(10):1271-1284. doi: 10.1016/j.jcmg.2023.03.009. Epub 2023 May 17.

    PMID: 37204382DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Mitral Valve ProlapseGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Vincent Probst, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Hervé Le Marec, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Jean-Jacques Schott, DR

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Le Tourneau, PU-PH

CONTACT

0617908670thletourneau@yahoo.fr

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 21, 2019

Study Start

December 1, 2010

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

FR(3)